TB Alliance Commercialization Partner, Mylan, Launches Named Patient Access Program for Pretomanid as part of New Regimen
The NPAP is designed for patients in countries where regulatory approval or other access mechanisms for pretomanid are not yet available
Pictured: Pretomanid Tablet, developed by TB Alliance
TB Alliance’s commercialization partner Mylan has launched a Named Patient Access Program (NPAP) for the anti-TB drug pretomanid. With national registrations underway, the NPAP is a means of providing access to pretomanid as part of the three-drug, all-oral BPaL regimen to patients in countries where the drug is not currently approved by a national regulatory authority.
To learn more about this program and apply, please visit www.accesspretomanid.com.
The following information has been made available by Mylan:
The NPAP is designed specifically for patients who live in countries where regulatory approval for pretomanid is not yet available to help ensure that physicians can consider pretomanid as a viable treatment option for patients regardless of where they live. Physicians can access this product contingent on the patient meeting the necessary eligibility criteria, and subject to final Mylan approval and local laws and regulations.
Eligibility criteria are as follows:
The patient seeking treatment has highly drug-resistant TB (adults with pulmonary extensively drug-resistant (XDR), treatment-intolerant or non-responsive multidrug resistant (MDR) tuberculosis) and there is no satisfactory alternative therapy available to treat the disease
The patient is not eligible to enroll in a clinical trial
The potential benefit of treatment outweighs the potential risk in the context of the disease as confirmed by the treating physician at the time of request
The product is not yet approved by the local regulatory body in the treating physician’s respective country
Pretomanid should be used as part of a combination regimen with bedaquiline and linezolid
How it works:
A qualified physician may submit a request for pretomanid for an individual patient via the website www.accesspretomanid.com. Received requests will be forwarded to an independent panel of experts at the Global TB Consilium, a global initiative through the Global TB Network, which will assess the anonymized patient case. Per the panel’s recommendation, Mylan will either approve or reject the request, and notify the requesting physician within seven business days of the original request. If approved, the physician will be directed to Mylan’s third-party service provider – WEP Clinical – which will work with the physician to collect the requisite documents (consents, waivers and permits) in order to import the drug. Physicians enrolling patients under the NPAP will be required to treat patients in accordance with the approved label.
Please e-mail accesspretomanid@mylan.com if you have any questions regarding this program
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